An interventional study of TruPlex HIV/HepB/Syphilis Rapid Test in HIV 1 Infection, HIV 2 Infection and Syphilis Infection, sponsored by bioLytical Laboratories. Recruiting at 3 sites in South Africa. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by bioLytical Laboratories · Not applicable, Interventional, and Screening
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Among 16 studies in Hepatitis B with a site in South Africa — 1 open to participants now, 4 under way, none of them phase 3. Hepatitis B · South Africa.
Among the 16 studies in Hepatitis B with a site in South Africa, this one is the 2nd largest by planned enrollment of the 15 interventional ones that give a count, is the only one that started in 2025, is one of 2 with no phase, and was the 16th registered.
1,046 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
Browse Hepatitis B studies →1 of the 16 studies in Hepatitis B with a site in South Africa is open now.
A study can be open while its sites in South Africa have not opened yet or have stopped. Only those recruiting at a site in South Africa →
Of the 80 Hepatitis B studies recruiting now, 40 (50%) set no upper age limit and 35 (44%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
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16 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 1,000 is above the median of 145 across 756 interventional studies indexed under Hepatitis B.
Median enrollment 283 across the 15 interventional studies, 455 across the 1 observational. Of the 12 that completed or were terminated, 8 (67%) have results posted.
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14 of 16 have an industry lead sponsor. The 7 most frequent:
bioLytical Laboratories is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
bioLytical Laboratories has 4 studies filed under Hepatitis B — fewer than ten, so there is no comparison to draw.
3 of the studies in Hepatitis B with a site in South Africa that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07563309bioLytical LaboratoriesA Study to Evaluate Performance, Usability, and Contrived Result Interpretation of TruPlex HIV/HepB/Syphilis Rapid Test | 2026-12-01 |
| NCT06497504GlaxoSmithKlineStudy of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus) | 2027-04-22 |
| NCT06537414GlaxoSmithKlineA Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) | 2027-05-31 |
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Among the 16 studies in Hepatitis B with a site in South Africa, from their registry updates:
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The objectives of this study are as follows:
To evaluate the clinical performance of the TruPlex test using capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings
To evaluate the usability of the TruPlex test through:
Structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.
To assess user interpretation accuracy through a contrived result interpretation questionnaire, where intended users evaluate a set of pre-defined test results (e.g., strong/weak positives, negatives, invalids).
To monitor test system reliability, including invalid rates.
The study is designed to evaluate TruPlex Test when used by trained users.
Non-invasive samples (fingerstick, EDTA whole blood, EDTA-plasma, and SST-serum) will be collected and tested on TruPlex tests by on-site trained operators. Capillary (fingerstick) whole blood and EDTA whole blood samples will be collected by healthcare professionals. The collected capillary and EDTA whole blood samples will be tested on the TruPlex tests. Subsequently, the EDTA whole blood and SST whole blood samples will be further processed to obtain EDTA plasma and SST serum, respectively, for testing on the TruPlex. Blood samples will be collected and sent to the central laboratory for confirmatory testing (HIV, Syphilis and HBsAg) using approved on-the-market assays. Any remaining samples will be stored for further discrepancy testing or future research use.
A minimum of two TruPlex Test lots will be used for the study.
The following studies will also be performed:
Usability evaluation to assess user experience and success in label comprehension of the TruPlex test via a questionnaire.
Contrived result interpretation with a minimum of 15 intended users across a minimum of 3 clinical sites. Participants will be trained healthcare professionals that are paid employees of the study sites. Participants will have prior experience using rapid tests. Participants will evaluate a set of contrived tests to determine and document if intended users can successfully interpret various TruPlex Test results that include - strong positive, weak positive, negative, and a range of invalid results.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject is getting tested for , and/or Syphilis, and/or for one or more of the following reasons:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Capillary blood, EDTA whole blood, EDTA plasma, and SST serum samples collected by trained operators in point-of-care settings will be tested on the TruPlex HIV/HepB/Syphilis Rapid Test.
Device: TruPlex HIV/HepB/Syphilis Rapid Test
A rapid in vitro diagnostic device designed to determine HIV, Syphilis and Hep B infection status
Performance Evaluation
The diagnostic sensitivity and specificity between TruPlex Test and approved confirmatory assays for HIV, Syphilis and Hep B infection status will be determined. Performance evaluation will be conducted for all sites combined. Test invalid rate will be tabulated and reported.
Time frame: 6 months
Usability Evaluation
Usability will be determined via a questionnaire completed by trained personnel who used the device during testing. The usability questionnaire will use a scale of one (1) to 5 (1 - very difficult/very unlikely to 5 - very easy/very likely), with a rating of 3 being satisfactory.
Time frame: 6 months
Contrived result interpretation evaluation
Trained operators will evaluate a panel of contrived (mock) TruPlexdevices. These devices are designed to represent a comprehensive range of test outcomes, including strong positives, weak positives, negatives and invalid results. Operators will interpret the results of the mock devices and record their interpretations which will be compared to the correct interpretation of the device.
Time frame: 6 months
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
Of 68 interventional studies with no phase under Hepatitis B, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 11 months is below that.
Primary completion moved once since we started tracking on Sep 25, 2026: Sep 2026 → Dec 2026, on Oct 2, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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